MOVIPREP ORANGE POWDER FOR ORAL SOLUTION

Transcript

Package Leaflet: Information for the User.

Powder for oral solution

For a list of active substances please see section 6.
Read all of this leaflet carefully before you start taking
this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others. It may be harmful even if their symptoms are the same
as yours.
- If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What MOVIPREP Orange is and what it is used for
2. Before you take MOVIPREP Orange
3. How to take MOVIPREP Orange
4. Possible side effects
5. How to store MOVIPREP Orange
6. Further information
1. WHAT MOVIPREP Orange IS AND WHAT IS IT USED FOR
MOVIPREP Orange is an orange-flavoured laxative contained in four
sachets. There are two large sachets (‘Sachet A’) and two small sachets
(‘Sachet B’). You need all these for one treatment.
You are taking MOVIPREP Orange to make your bowels clean so that they
are ready for examination. MOVIPREP Orange works by emptying the
contents of your bowels, so you should expect to have watery bowel
movements.
2. BEFORE YOU TAKE MOVIPREP Orange
Do not take MOVIPREP Orange if you suspect or your
doctor suspects:
• you are allergic (hypersensitive) to macrogol 3350 or any of the other
ingredients of MOVIPREP Orange.
• you have an obstruction in your intestine (gut).
• you have a perforated gut wall.
• you have a disorder of stomach emptying.
• you have paralysis of the gut (often occurs after an operation to
the abdomen).
• you suffer from phenylketonuria. This is an hereditary inability of
the body to use a particular amino acid. MOVIPREP Orange
contains a source of phenylalanine.
• your body is unable to produce enough glucose-6-phosphate
dehydrogenase.
• you have toxic megacolon (a severe complication of acute colitis).
Take special care with MOVIPREP Orange
If you are in poor health or have a serious medical condition, you should
be particularly aware of the possible side effects listed in section 4.
Contact your doctor or pharmacist if you are concerned.
You should tell your doctor before taking MOVIPREP Orange if you have
any of the following:
• you need to thicken fluids in order to swallow them safely.
• a tendency to regurgitate swallowed drink, food or acid from
the stomach.
• kidney disease.
• heart failure.
• dehydration.
• acute flare of inflammatory bowel disease (Crohn's disease or
ulcerative colitis).
MOVIPREP Orange should not be given to patients with impaired
consciousness without medical supervision.
Taking other medicines
If you are taking other medicines take them at least one hour
before taking MOVIPREP Orange or at least one hour afterwards
because they may be flushed through your digestive system and
not work so well.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Taking MOVIPREP Orange with food and drink
Do not take any solid food from when you start to take MOVIPREP
Orange until after the examination.

Pregnancy and breast-feeding
There are no data on the use of MOVIPREP Orange during
pregnancy or lactation and it should only be used if considered
essential by the physician. So if you are pregnant or breast feeding
talk to your doctor before taking MOVIPREP Orange.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
MOVIPREP Orange does not affect your ability to drive or use
machines.
Important information about some of the ingredients of
MOVIPREP Orange
This medicinal product contains 56.2 mmol of absorbable sodium
per litre. To be taken into consideration by patients on a controlled
sodium diet. This medicinal product contains 14.2 mmol of
potassium per litre. To be taken into consideration by patients with
reduced kidney function or patients on a controlled potassium diet.
Contains a source of phenylalanine. May be harmful for people
with phenylketonuria. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3. HOW TO TAKE MOVIPREP Orange
Always take MOVIPREP Orange exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure. The usual dose is 2 litres of solution, which is made up as
follows:
This pack contains 2 clear bags each containing one pair of
sachets: Sachet A and Sachet B. Each pair of sachets (A and B) is to
be dissolved in one litre of water. This pack is therefore sufficient to
make up 2 litres of MOVIPREP Orange solution.
Before you take MOVIPREP Orange, please read carefully the
following instructions. You need to know:
• When to take MOVIPREP Orange
• How to prepare MOVIPREP Orange solution
• How to drink MOVIPREP Orange
• What you should expect to happen
When to take MOVIPREP Orange
You should have been given instructions about when to take
MOVIPREP Orange by your doctor or nurse. Your treatment with
MOVIPREP Orange must be completed before your
clinical examination and can be taken:
either divided as 1 litre of MOVIPREP Orange in the evening and
1 litre in the early morning of the day of the examination,
or 2 litres in the evening before the examination.
Important: Do not take any solid food from when you
start to take MOVIPREP Orange until after the
examination.
How to prepare MOVIPREP Orange
• Open one clear bag and remove the sachets A and B
• Add the contents of BOTH sachet A and sachet B to a 1 litre
container
• Pour 1 litre of water into the container and stir until all the
powder has dissolved and the MOVIPREP Orange solution is
clear or slightly hazy. This may take up to 5 minutes.

How to drink MOVIPREP Orange
Drink the first litre of the MOVIPREP Orange solution over one to
two hours. Try to drink a glassful every 10-15 minutes.
When you are ready, make up and drink the second litre of
MOVIPREP Orange solution made up with the contents of the
sachets A and B from the remaining bag.
During the course of this treatment, you are recommended to drink
a further one litre of clear liquid to prevent you feeling very thirsty
and becoming dehydrated. Water, clear soup, fruit juice (without
pulp), soft drinks, tea or coffee (without milk) are all suitable. These
drinks can be taken at any time you choose.
What you should expect to happen
When you start drinking the MOVIPREP Orange solution, it is
important that you stay close to a toilet. At some point, you will
start to experience watery bowel movements. This is quite normal
and indicates that the MOVIPREP Orange solution is working. The
bowel movements will stop soon after you have finished drinking.
If you follow these instructions, your bowel will be clear, and this
will help you to have a successful examination.

If you take more MOVIPREP Orange than you should
If you take more MOVIPREP Orange than you should you may
develop excessive diarrhoea, which can lead to dehydration.
Take generous amounts of fluid, especially fruit juices. If you are
worried contact your doctor or pharmacist.
If you forget to take MOVIPREP Orange
If you forget to take MOVIPREP Orange take the dose as soon as
you realize you have not taken it. If this is several hours after the
time when you should have taken it, contact your doctor or
pharmacist for advice. It is important that you complete your
preparation at least an hour before your procedure.
If you have any further questions on the use of this product, ask
you doctor or pharmacist.
Children
MOVIPREP Orange should not be taken by children
aged below 18 years.
4. POSSIBLE SIDE EFFECTS
Like all medicines, MOVIPREP Orange can have side effects
although not everybody gets them.
It is normal to get diarrhoea when you take MOVIPREP Orange.
Very common side effects (i.e. affects more than 1 user in 10) are:
Abdominal pain, abdominal distension, tiredness, feeling generally
unwell, soreness of the anus and nausea.
Common side effects (i.e. affects 1 to 10 users in 100) are: Hunger,
problems sleeping, dizziness, headache, vomiting, indigestion and
chills.
Uncommon side effects (i.e. affects 1 to 10 users in 1,000) are:
Discomfort, difficulties swallowing and change to tests of liver
function.
The following side effects have sometimes been seen but it is not
known how often they occur because the frequency cannot be
estimated from the available data: flatulence (wind), temporary
increase in blood pressure, retching (straining to vomit), very low
blood sodium levels that can cause convulsions (fits) and changes
to the levels of salts in the blood such as decreased bicarbonate,
increased or decreased calcium; increased or decreased chloride;
decreased phosphate. Blood potassium and sodium levels could
also decrease particularly in patients taking medicines that affect
the kidney such as ACE Inhibitors and diuretics used for the
treatment of heart disease.
These reactions usually only occur for the duration of the
treatment. Should they persist, consult your doctor.
Allergic reactions may occur.
If you experience any of the following, stop your intake of
MOVIPREP Orange and contact your doctor immediately.
You should not take any more MOVIPREP Orange until you have
checked with your doctor.
• rash or itching
• swelling of your face, ankles or other part of your body
• palpitations
• extreme fatigue
• shortness of breath
If you do not have a bowel movement within 6 hours of taking
MOVIPREP Orange, stop the intake and contact your doctor
immediately.
If any of the side effects becomes serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

10037802

5. HOW TO STORE MOVIPREP ORANGE
Keep out of the reach and sight of children.
Do not use MOVIPREP Orange after the expiry date which is stated on
the carton and sachets.
The expiry date refers to the last day of the month.
Keep MOVIPREP Orange sachets at room temperature (not above 25ºC).
After you have dissolved MOVIPREP Orange in the water, the solution
may be stored (keeping covered) at room temperature (not above
25ºC). It may also be stored in the fridge (2ºC - 8ºC). Do not keep it for
more than 24 hours.
Medicines should not be disposed of via waste water or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help protect the environment.
6. FURTHER INFORMATION
What MOVIPREP Orange contains
The active substances are:
Sachet A
Macrogol (also known as polyethylene glycol) 3350
Sodium sulphate anhydrous
Sodium chloride
Potassium chloride

100
7.500
2.691
1.015

g
g
g
g

Sachet B
Ascorbic acid
4.700 g
Sodium ascorbate
5.900 g
The concentration of electrolyte ions when both sachets are
made up to one litre of solution is as follows:
Sodium
181.6 mmol/l
(of which not more than 56.2 mmol is absorbable)
Sulphate
52.8 mmol/l
Chloride
59.8 mmol/l
Potassium
14.2 mmol/l
Ascorbate
29.8 mmol/l
Other ingredients are:
Orange flavour (containing natural flavouring substances and
preparations maltodextrin, dextrose, aspartame (E951) and
acesulfame potassium (E950) as sweeteners.
What MOVIPREP Orange looks like and contents
of the pack
This pack contains 2 clear bags each containing one pair of sachets:
Sachet A and Sachet B. Each pair of sachets (A and B) is to be
dissolved in one litre of water.
MOVIPREP Orange powder for oral solution in sachets is available
in pack sizes of 1, 10, 40, 80, 160 and 320 packs of a single
treatment. Hospital packs of 40 single treatments. Not all pack sizes
may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Norgine Pharmaceuticals Limited, Widewater Place,
Moorhall Road, Harefield, UB9 6NS, UK
Manufacturer:
Norgine Limited, New Road, Hengoed, Mid Glamorgan,
CF82 8SJ, United Kingdom.
The medicinal product is authorised in the Member States
of the EEA under the following names:
Country
Tradename
Austria
MOVIPREP Orange
Belgium
MOVIPREP Sinaas/Orange
Denmark
MOVIPREP Appelsin
Finland
MOVIPREP Appelsiini
Germany
MOVIPREP Orange
Ireland
MOVIPREP Orange
Italy
MOVIPREP Arancio
Luxembourg
MOVIPREP Sinaas/Orange
Netherlands
MOVIPREP Orange
Spain
MOVIPREP sabor Naranja
Sweden
MOVPREP APELSIN
United Kingdom
MOVIPREP Orange

This leaflet was last approved in 07/2012
The following information is intended for medical or healthcare
professionals only.
Note for medical staff:
MOVIPREP Orange should be administered with caution to fragile
patients in poor health or patients with serious clinical impairment
such as:
• impaired gag reflex, or with a tendency to aspiration or
regurgitation
• impaired consciousness
• severe renal insufficiency (creatinine clearance <30 ml/min)
• cardiac impairment (NYHA grade III or IV)
• dehydration
• severe acute inflammatory disease
The presence of dehydration should be corrected before the
use of MOVIPREP Orange.
Semi-conscious patients or patients prone to aspiration or
regurgitation should be closely observed during administration
especially if this is via a nasogastric route.
MOVIPREP Orange should not be given to unconscious patients.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.